INDIANAPOLIS, June 8, 2017 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) will present data from 14 abstracts, including
late-breaking Phase 3 data for two investigational treatments for
migraine, at the American Headache Society (AHS) annual scientific
meeting, taking place June 8-11 in
Boston.
Lilly will highlight new, Phase 3 primary and secondary endpoint
data in three late-breaking presentations for galcanezumab for the
prevention of episodic and chronic migraine. Galcanezumab is a
once-monthly, subcutaneously injected calcitonin gene-related
peptide (CGRP) antibody currently being studied as a potential
treatment for the prevention of migraine and cluster headache.
Lilly will also present late-breaking Phase 3 data from a study
evaluating the efficacy and safety of lasmiditan for the acute
treatment of migraine. Lasmiditan is an oral, first-in-class
molecule that could represent the first significant innovation for
the acute treatment of migraine in more than two decades.
"For more than 25 years, Lilly's expert clinicians and
researchers have worked to develop innovative treatments that can
improve the lives of patients with migraine and address the
challenges healthcare providers face in treating this serious
disease," said Robert Conley, M.D.,
Distinguished Lilly Scholar, neuroscience. "We are truly excited to
present a range of new data from our migraine portfolio, which
support the potential use of both galcanezumab and lasmiditan as
much-needed, new treatment options for patients suffering from
migraine."
Studies, as well as the dates and times of the data sessions,
are highlighted below.
Late-Breaking Oral Presentations:
Saturday, June 10, 2017 –
9:40-9:50 a.m. ET
- IOR11B: Lasmiditan (200 mg and 100 mg) Compared to
Placebo for Acute Treatment of Migraine
-
- Presenter: Sheena Aurora, M.D., medical fellow and global
launch leader, galcanezumab, Eli Lilly and Company, Indianapolis, IN
Saturday, June 10, 2017 –
9:50-10:00 a.m. ET
- IOR12LB: Phase 3 Study (EVOLVE-2) of Galcanezumab in
Episodic Migraine
-
- Presenter: Robert Conley, M.D.,
Distinguished Lilly Scholar, neuroscience, Eli Lilly and Company,
Indianapolis, IN
Poster Presentations:
Friday, June 9, 2017 –
1:15 p.m.-2:30 p.m. ET
- PF04: Economics of Inhaled Oxygen Use as an Acute
Therapy for Cluster Headache in the
United States of America
-
- Presenter: Stewart Tepper, M.D.,
Geisel School of Medicine, Dartmouth
College, Hanover, NH
- PF08: Galcanezumab Administration Was Not Associated
with Increase in Blood Pressure in Patients with
Osteoarthritis
-
- Presenter: Sheena Aurora, M.D., medical fellow and global
launch leader, galcanezumab, Eli Lilly and Company, Indianapolis, IN
- PF10: Tolerability, Pharmacokinetics and
Pharmacodynamics of Galcanezumab in Healthy Subjects Following a
Subcutaneous Administration of a Lyophilized Formulation or a
Solution Formulation
-
- Presenter: William Kielbasa,
Ph.D., research advisor, Eli Lilly and Company, Indianapolis, IN
- PF14: Medication Use among Patients Diagnosed with
Headache and Migraine in a Large National Commercial Payer
Database: A Retrospective Study
-
- Presenter: Paula Morrow, M.S.N.,
senior clinical research scientist, Eli Lilly and Company,
Indianapolis, IN
Saturday, June 10, 2017 –
12:30-2:00 p.m. ET
- PS03: Clinical Characteristics and Treatment Patterns
among Patients with Diagnostic Codes for Cluster Headache in the
U.S. Healthcare Claims Data
-
- Presenter: James Martinez, M.D.,
medical fellow, Eli Lilly and Company, Indianapolis, IN
- PS04: Measures of Functioning Using MSQ v2.1 in Patients
with a History of Episodic Migraine and Treated with Galcanezumab
or Placebo Injections in a Phase 2 Clinical Trial
-
- Presenter: Sheena Aurora, M.D., medical fellow and global
launch leader, galcanezumab, Eli Lilly and Company, Indianapolis, IN
- PS05: Hepatic Safety of Galcanezumab in Patients with
Migraine: Results of Three Phase 2 Double-Blind Placebo-controlled
Trials
-
- Presenter: Vladimir Skljarevski,
M.D., senior medical fellow, Eli Lilly and Company, Indianapolis, IN
- PS06: Factors Associated with Significant Reduction in
Migraine Headache Days: A Post-Hoc Analysis of a Phase 2
Placebo-Controlled Trial in Patients Treated with Galcanezumab
-
- Presenter: Sheena Aurora, M.D., medical fellow and global
launch leader, galcanezumab, Eli Lilly and Company, Indianapolis, IN
- PS18: The Relationship between Headache Frequency and
Illness Burden Prior to Treatment Randomization in Two Phase 3
Episodic Migraine Clinical Trials
-
- Presenter: Virginia Stauffer,
Pharm.D., research advisor, Eli Lilly and Company, Indianapolis, IN
- PS19: Safety and Tolerability of Galcanezumab in a Phase
2 Migraine Prevention Study
-
- Presenter: Tina Oakes, Ph.D., research advisor, Eli Lilly
and Company, Indianapolis, IN
- PS88LB: Phase 3 Study (EVOLVE-1) of Galcanezumab in
Episodic Migraine
-
- Presenter: Virginia Stauffer,
Pharm.D., research advisor, Eli Lilly and Company, Indianapolis, IN
- PS89LB: A Phase 3 Placebo-Controlled Study of
Galcanezumab in Patients with Chronic Migraine: Results from the
3-Month Double-Blind Treatment Phase of the REGAIN Study
-
- Presenter: Holland Detke, Ph.D., research advisor, Eli Lilly
and Company, Indianapolis, IN
About Migraine
Migraine is a disabling neurological
disease characterized by recurrent episodes of severe headache, and
is often accompanied by other symptoms including nausea, vomiting,
sensitivity to light and sound, and changes in
vision.[1],[2] More than 38 million Americans have
migraine, with three times more women affected by migraine compared
to men.[3] Of the approximately 40 percent of
patients suffering from migraine for whom prevention is
appropriate, only 13 percent are currently receiving
therapy.[4],[5], [6] Results from the Second
International Burden of Migraine study show that side effects of
treatment play a role in this disconnect, with up to 53 percent of
respondents discontinuing migraine prevention therapy because of
side effects.[7] According to the Migraine Research
Foundation, healthcare and lost productivity costs associated with
migraine are estimated to be as high as $36
billion annually in the U.S., yet it remains
under-recognized and under-treated.[3],[7]
About Cluster Headache
Cluster headache, often
characterized as the most painful of all headaches, is a
neurological disease characterized by recurrent, severe headaches
on one side of the head, usually behind or around one
eye.2,[8] Cluster headaches –
commonly known as "attacks" – typically last between 15 minutes to
more than two hours and can recur on the same day and occur daily
to multiple times a day for weeks or longer, followed by periods of
time in which no attacks occur.[5] Cluster headache
is classified as "chronic" when attacks occur for more than one
year without a remission period, or with remission lasting less
than one month.[5]
About Lilly in Migraine
Lilly has been committed to
helping people suffering from migraine for over 25 years,
investigating more than a dozen different compounds for the
treatment of headache disorders. These research programs have
accelerated understanding of this disease and advanced the
development of Lilly's comprehensive late-stage development
programs studying galcanezumab for prevention of migraine and
lasmiditan for the acute treatment of migraine. Our goal is to make
life better for people with migraine by offering comprehensive
solutions to prevent or stop this disabling disease. The combined
clinical, academic and professional experience of our experts helps
us to build our research portfolio, identify challenges for
healthcare providers and pinpoint the needs of patients living with
migraine.
About Galcanezumab
Galcanezumab is a monoclonal
antibody specifically designed to bind to and inhibit the activity
of calcitonin gene-related peptide (CGRP), which is believed to
play a role in migraine and cluster headache. Galcanezumab is an
investigational once-monthly, self-administered injection under
evaluation for the prevention of migraine and cluster headache.
About Lasmiditan
Lasmiditan is an
investigational, first-in-class molecule under evaluation for the
acute treatment of migraine. Lasmiditan selectively targets 5HT1F
receptors expressed in the trigeminal pathway, and has been
designed for the acute treatment of migraine without the
vasoconstrictor activity associated with previous generations of
migraine therapies. Data from the first of two Phase 3 studies was
announced in 2016, with topline results from the second Phase 3
trial expected later this year. In January
2017, Lilly announced an agreement to acquire CoLucid
Pharmaceuticals, including lasmiditan, which was originally
discovered at Lilly.
About Eli Lilly and Company
Lilly is a global
healthcare leader that unites caring with discovery to make life
better for people around the world. We were founded more than a
century ago by a man committed to creating high-quality medicines
that meet real needs, and today we remain true to that mission in
all our work. Across the globe, Lilly employees work to discover
and bring life-changing medicines to those who need them, improve
the understanding and management of disease, and give back to
communities through philanthropy and volunteerism. To learn more
about Lilly, please visit us at www.lilly.com and
www.lilly.com/newsroom/social-channels.
P-LLY
This press release contains forward-looking statements (as that
term is defined in the Private Securities Litigation Reform Act of
1995) about galcanezumab and lasmiditan as potential treatments for
patients with migraine, and reflects Lilly's current belief.
However, as with any pharmaceutical product, there are
substantial risks and uncertainties in the process of development
and commercialization. Among other things, there can be no
guarantee that future study results will be consistent with the
results to date, that galcanezumab or lasmiditan will achieve their
primary study endpoints or receive regulatory approvals. For
further discussion of these and other risks and uncertainties, see
Lilly's most recent Form 10-K and Form 10-Q filings with the United
States Securities and Exchange Commission. Except as required by
law, Lilly undertakes no duty to update forward-looking statements
to reflect events after the date of this release.
[1] Headache disorders. World Health Organization
website. http://www.who.int/mediacentre/factsheets/fs277/en/.
Accessed May 11, 2017.
[2] Russo AF. Calcitonin gene-related peptide (CGRP):
a new target for migraine. Annual Review of Pharmacology and
Toxicology. 2015;55:533-552.
[3] Migraine facts. Migraine Research Foundation
website.
http://migraineresearchfoundation.org/about-migraine/migraine-facts/.
Accessed May 11, 2017.
[4] Lipton RB, Bigal ME, Diamond M, et al. Migraine
prevalence, disease burden and the need for preventive therapy.
Neurology. 2007;68(5):343-349.
[5] Lafata, JE, Tuniceli O, Cerghet M, et al. The use
of migraine preventive medications among patients with and without
migraine headaches. Cephalagia. 2010;30(1):97-104.
[6] Diamond S, Bigal ME, Silberstein S, et al.
Patterns of diagnosis and acute and preventive treatment for
migraine in the United States:
results from the American Prevalence and Prevention study.
Headache. 2007;47(3):355-363.
[7] Blumenfeld AM, Bloudek LM, Becker WJ, et al.
Patterns of use and reasons for discontinuation of prophylactic
medications for episodic migraine and chronic migraine: results
from the Second International Burden of Migraine Study (IBSM-II).
Headache. 2013;53(4):644-655.
[8] Treatment for cluster headache. American Migraine
Foundation website.
https://americanmigrainefoundation.org/understanding-migraine/treatment-of-cluster-headache/.
Accessed April 19, 2017.
Refer to: Jen Dial;
dial_jennifer_kay@lilly.com; 317-220-1172 (Media)
Phil Johnson,
johnson_philip_l@lilly.com; 317-655-6874
(Investors)
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SOURCE Eli Lilly and Company